Positive Phase 3 RASolute 302 trial results, showing median overall survival of 13.2 months versus 6.7 months with chemotherapy in previously treated metastatic pancreatic ductal adenocarcinoma patients with RAS G12 mutations, along with FDA acceptance of the new drug application in late July 2026, underpin the 71.5% market-implied odds of approval this year. Breakthrough Therapy, Orphan Drug, and National Priority Voucher designations further support expedited review under the Commissioner’s pilot program, while the May 2026 expanded access authorization reflects regulatory recognition of unmet need in RAS-driven tumors. These factors indicate strong trader consensus on timely approval, though final timing depends on review outcomes and any additional data requests.
Experimentelle KI-generierte Zusammenfassung mit Polymarket-Daten. Dies ist keine Handelsberatung und spielt keine Rolle bei der Auflösung dieses Marktes. · AktualisiertFDA genehmigt Daraxonrasib in diesem Jahr?
Ja
Ja
This market will resolve to "Yes" if the U.S. Food and Drug Administration (FDA) grants a full or conditional approval for a drug product whose active ingredient is Revolution Medicines’ daraxonrasib (including any brand name or identifier) for any use between market creation and December 31, 2026, 11:59 PM ET. Otherwise, this market will resolve to "No."
An approval is defined as:
For new drugs: FDA issuance of an approval letter for a New Drug Application (NDA) or Biologics License Application (BLA)
For already-marketed drugs seeking new indications: FDA approval of a supplemental NDA (sNDA) or supplemental BLA (sBLA) for the specific indication referenced
For generic drugs: FDA approval of an Abbreviated New Drug Application (ANDA)
For biosimilars: FDA approval of a 351(k) application
The following constitute qualifying approvals:
Standard approval (traditional approval based on clinical benefit), Accelerated approval (based on surrogate endpoints), Approval with Risk Evaluation and Mitigation Strategy (REMS), Approval with restricted distribution or indication limitations, except compassionate use/expanded access programs
The following do not constitute qualifying approvals:
Approvable letters that require additional actions before approval
Tentative approvals pending patent or exclusivity expiration
FDA requests for additional information or studies
Extension of Prescription Drug User Fee Amendments dates
Approval for compassionate use or expanded access programs only
Approval only for export or for use outside the United States
Emergency Use Authorization (EUA) without full approval
Complete Response Letters (CRLs) indicating the application cannot be approved in its current form
If the listed drug is approved within this market’s timeframe, the market will resolve to "Yes," regardless of potential Advisory Committee votes against approval or later withdrawal of approval.
Conditional approvals may include post-marketing requirements or commitments and still qualify.
The primary resolution source will be official information from the FDA; however, a consensus of credible reporting will also be used.
Markt eröffnet: May 13, 2026, 5:28 PM ET
Resolver
0x65070BE91...This market will resolve to "Yes" if the U.S. Food and Drug Administration (FDA) grants a full or conditional approval for a drug product whose active ingredient is Revolution Medicines’ daraxonrasib (including any brand name or identifier) for any use between market creation and December 31, 2026, 11:59 PM ET. Otherwise, this market will resolve to "No."
An approval is defined as:
For new drugs: FDA issuance of an approval letter for a New Drug Application (NDA) or Biologics License Application (BLA)
For already-marketed drugs seeking new indications: FDA approval of a supplemental NDA (sNDA) or supplemental BLA (sBLA) for the specific indication referenced
For generic drugs: FDA approval of an Abbreviated New Drug Application (ANDA)
For biosimilars: FDA approval of a 351(k) application
The following constitute qualifying approvals:
Standard approval (traditional approval based on clinical benefit), Accelerated approval (based on surrogate endpoints), Approval with Risk Evaluation and Mitigation Strategy (REMS), Approval with restricted distribution or indication limitations, except compassionate use/expanded access programs
The following do not constitute qualifying approvals:
Approvable letters that require additional actions before approval
Tentative approvals pending patent or exclusivity expiration
FDA requests for additional information or studies
Extension of Prescription Drug User Fee Amendments dates
Approval for compassionate use or expanded access programs only
Approval only for export or for use outside the United States
Emergency Use Authorization (EUA) without full approval
Complete Response Letters (CRLs) indicating the application cannot be approved in its current form
If the listed drug is approved within this market’s timeframe, the market will resolve to "Yes," regardless of potential Advisory Committee votes against approval or later withdrawal of approval.
Conditional approvals may include post-marketing requirements or commitments and still qualify.
The primary resolution source will be official information from the FDA; however, a consensus of credible reporting will also be used.
Resolver
0x65070BE91...Positive Phase 3 RASolute 302 trial results, showing median overall survival of 13.2 months versus 6.7 months with chemotherapy in previously treated metastatic pancreatic ductal adenocarcinoma patients with RAS G12 mutations, along with FDA acceptance of the new drug application in late July 2026, underpin the 71.5% market-implied odds of approval this year. Breakthrough Therapy, Orphan Drug, and National Priority Voucher designations further support expedited review under the Commissioner’s pilot program, while the May 2026 expanded access authorization reflects regulatory recognition of unmet need in RAS-driven tumors. These factors indicate strong trader consensus on timely approval, though final timing depends on review outcomes and any additional data requests.
Experimentelle KI-generierte Zusammenfassung mit Polymarket-Daten. Dies ist keine Handelsberatung und spielt keine Rolle bei der Auflösung dieses Marktes. · Aktualisiert



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